Actively Recruiting
A Study of VRD-based Regimen Combined With CART-ASCT-CART2 Treatment in Patients With Primary Plasma Cell Leukemia
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2026-03-02
20
Participants Needed
1
Research Sites
205 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-arm, open-label study to evaluate the efficacy and safety of VRD-based Regimen (Bortezomib, Lenalidomide and Dexamethasone) combined with CART-ASCT-CART2 in Chinese patients with newly diagnosed primary plasma cell leukemia.
CONDITIONS
Official Title
A Study of VRD-based Regimen Combined With CART-ASCT-CART2 Treatment in Patients With Primary Plasma Cell Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide voluntary written informed consent before any study procedures
- Age between 18 and 65 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Life expectancy of at least 3 months
- Definitive diagnosis of primary plasma cell leukemia meeting specific blood criteria
- No prior anti-myeloma therapy received
- Measurable disease by defined monoclonal protein or free light chain levels
- Bone marrow sample confirmed BCMA-positive by flow cytometry or pathology
- Adequate blood counts: ANC ≥ 1.0 x 10^9/L and platelets ≥ 50 x 10^9/L
- Liver and kidney function within specified limits
- Able to take recommended prophylactic anticoagulant therapy
- Women must not be breastfeeding or pregnant and agree to avoid pregnancy during and 12 months after study; men agree their partner will not become pregnant during this time
- Willing and able to complete study procedures and follow-up
You will not qualify if you...
- Having secondary plasma cell leukemia
- Central nervous system involvement
- Ineligible for autologous stem cell transplantation due to severe cardiopulmonary disorders
- Known intolerance, allergy, or resistance to study drugs or BCMA-CAR-T cells
- Major surgery within 2 weeks before randomization or not fully recovered
- Unstable or active cardiovascular disease including recent heart events or uncontrolled hypertension
- Positive for HIV or active hepatitis B or C infection without confirmed viral control
- Ongoing active infection
- History of other malignancies unless disease-free for 5 years
- Pregnant or breastfeeding females
- Active gastrointestinal problems affecting medication intake
- Any serious mental or medical condition affecting treatment or consent
- Contraindications to necessary medications or supportive therapies
- Any other medical condition interfering with participation
- Participation in other experimental therapies
- Unwillingness or inability to comply with study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, China
Actively Recruiting
Research Team
G
Gang An, PhD&MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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